On November 15 the respected organization, originally founded by consumer advocate Ralph Nader, formally petitioned the FDA to ban the sale of olmesartan medoxomil – Benicar – due to the potential for Benicar side effects to which Public Citizen refers as ‘life-threatening.’
“Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits,” the organization warned in a press release issued on November 15, following release of the 20-page petition to the FDA.
The FDA has formally acknowledged receiving the petition. What is not known is what the regulator will do with the petition. Historically, the regulator has taken long stretches of time, often measured in years, in order to analyze and ponder such a request. In the meantime, patients prescribed the hypertension drug continue to suffer Benicar side effects such as Benicar illness and weight loss associated with a severe gastrointestinal condition that often lands a patient in the hospital.
The condition is known as sprue-like enteropathy, a malady that “leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss,” Public Citizen states. “The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion.
“However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.”
The reference to sprue and celiac disease is Public Citizen’s nod to the fact that sometimes sprue-like enteropathy is misdiagnosed as a celiac disorder – when in fact, it is anything but.
Benicar is a hypertension drug indicated for the treatment and management of high blood pressure, and in that role olmesartan is effective. However the Benicar side effects, and risks associated with olmesartan outweigh the benefit, according to Public Citizen and others who note the presence of other hypertension medications that are equally effective in lowering blood pressure without such dire side effects as sprue-like enteropathy and the Benicar illness and weight loss olmesartan is alleged to cause.
Benicar, together with Azor, Benicar HCT, and Tribenzor, are unique in their association with sprue-like enteropathy. It is why so many plaintiffs reference Benicar defective products in their allegations, and why Public Citizen wants them off the market.
“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”
The advocate, in its petition to the FDA, noted that researchers at the Mayo Clinic published the first study documenting the link between olmesartan use and sprue-like enteropathy. That was in 2012. The following year, the FDA concluded that olmesartan “can cause” sprue-like enteropathy, and the regulator issued a safety warning about the medication.
“However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling,” Public Citizen said.
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The consumer advocacy group, on November 15 of this year, formally petitioned the FDA to “immediately require the removal from the market of all medications containing olmesartan medoxomil, including medications branded as Azor, Benicar, Benicar HCT, and Tribenzor, as well as all generic versions of these drugs.”
It is too early to tell if Public Citizen might consider launching a Benicar lawsuit against the FDA alleging Benicar defective products. In the past, Public Citizen has pressed the FDA in the courts if the organization feels the regulator is dragging its heels on an issue, while patients continue to suffer.